CN104474202B - A kind of pharmaceutical composition for the treatment of anorexia - Google Patents

Abstract

The invention belongs to the technical field of medicine, and in particular relates to a pharmaceutical composition for treating anorexia. The pharmaceutical composition comprises the following components: Atractylodes Rhizoma Atractylodes Rhizome, Chinese Yam, Tangerine Peel, Epimedium, Hawthorn, Astragalus, Gorgon, Cuscuta, Albizia Julibrissin, and Platycodon grandiflorum. The pharmaceutical composition of the present invention is a Chinese herbal medicine, its preparation process is mature, and its raw materials are easy to obtain. It has definite curative effect on various common anorexia diseases, especially anorexia of spleen-stomach-qi deficiency type in children, treats both symptoms and root causes, has little side effects, and can effectively cure anorexia without recurrence after treatment. disease patients.

Description

A kind of medicinal composition for treating anorexia

technical field

The invention belongs to the technical field of medicine, and in particular relates to a pharmaceutical composition for treating anorexia.

Background technique

Anorexia refers to the symptoms of long-term loss of appetite or lack of appetite. Anorexia patients often feel nauseous and vomit as soon as they hear about eating, and always say that they are not hungry. In the early stage of the disease, the patient only loses weight and can still work and study normally. Due to not being greedy for food, loss of appetite, or even refusal to eat, and continuous weight loss. In severe cases, accompanied by nutritional deficiencies, dizziness, dizziness, dizziness, hypoglycemia and other reactions often occur, sweating after a little activity, hair loss, edema, hypotension , hypothermia, bradycardia, and even water electrolyte and acid-base balance disorders. At the same time, due to the long-term deliberate suppression of appetite, the patient does not eat enough, and the secretion of digestive juice decreases, causing further reduction in food intake.

If sick children do not receive timely and effective treatment, they may suffer from malnutrition, vitamin D deficiency rickets, recurrent respiratory tract infection and other diseases. Most of the Western medicine treatment is to correct the balance of water and electrolytes. Oral administration and intravenous injection are often used to supplement digestive enzymes, trace elements, antibiotics and other chemically synthesized drugs, which have large side effects and poor patient compliance. Traditional Chinese medicine has rich experience in the treatment of anorexia, and the syndrome differentiation lies in the spleen or stomach. In the stomach, the deficiency of stomach yin is the main symptom, with symptoms of anorexia, dry mouth, polydipsia, dry stool, red tongue and little fluid. In the case of the spleen, the spleen is mainly impaired, and the symptoms include anorexia, pale complexion, abdominal distension and loose stools, pale tongue with white coating. The general treatment principle is to invigorate the spleen, nourish the yin and benefit the stomach. Using traditional Chinese medicine prescriptions and dialectical treatment, the curative effect is definite and the side effects are small. Therefore, it is very necessary to study effective Chinese medicine compositions for the treatment of anorexia.

Contents of the invention

The invention provides a new pharmaceutical composition for treating anorexia. The pharmaceutical composition has fast onset of action, good curative effect and less toxic and side effects. Astragalus, Gorgon, Dodder, Albizia, Bellflower.

In the pharmaceutical composition of the present invention, the Atractylodes Rhizome is bitter, sweet and warm. Return spleen, stomach warp. Invigorating the spleen and replenishing qi, drying dampness and diuresis, antiperspirant, antiabortive. For insufficiency of the spleen, lack of food, abdominal distension and diarrhea, dizziness and palpitation due to phlegm and retention, edema, spontaneous sweating, restless fetal movement. Tubaizhu strengthens the spleen, harmonizes the stomach and relieves miscarriage. For insufficiency of the spleen, lack of food, diarrhea and loose stool, restless fetal movement.

Chinese yam medicine, sweet, flat. Return spleen, lung, kidney channel. Invigorate the spleen and nourish the stomach, promote body fluid and benefit the lung, invigorate the kidney and astringent essence. Used for insufficiency of the spleen, lack of food, persistent diarrhea, dyspnea and cough due to lung deficiency, spermatorrhea due to kidney deficiency, leukorrhea, frequent urination, deficiency-heat and quenching thirst. Fried yam with bran nourishes the spleen and stomach. Used for insufficiency of the spleen, lack of food, loose stools, and excessive leucorrhea.

Tangerine peel, bitter, pungent, warm. Return lung, spleen channel. Regulating qi and invigorating the spleen, drying dampness and resolving phlegm. It is used for fullness in the chest cavity, vomiting and diarrhea due to lack of food, and cough with excessive phlegm.

Epimedium, pungent, sweet, warm. Return liver, kidney channel. Tonify kidney yang, strengthen muscles and bones, and dispel rheumatism. For impotence and nocturnal emission, flaccidity of muscles and bones, rheumatic arthralgia, numbness and contracture; menopausal hypertension.

Hawthorn, sour, sweet, slightly warm. Return spleen, stomach, liver channel. Dispelling food and invigorating the stomach, promoting qi and dispelling blood stasis. For stagnation of meat, fullness in the epigastric cavity, diarrhea and abdominal pain, amenorrhea due to blood stasis, postpartum stasis, tingling pain in trusted subordinates, hernia pain; hyperlipidemia. Jiao Hawthorn enhances digestion and guides stagnation. Used for stagnation of meat, diarrhea and dysentery.

Radix Astragali, sweet, warm. Return lung, spleen channel. Invigorating qi and solidifying the surface, diuretic to support toxin, evacuation of pus, astringing sores and promoting granulation. For qi deficiency and fatigue, lack of appetite, loose stools, subsidence of middle qi, chronic diarrhea and prolapse of the anus, blood in stool and metrorrhagia, spontaneous sweating due to surface deficiency, edema due to deficiency of qi, carbuncle and gangrene that are difficult to burst, long-term ulceration, blood deficiency, flaccidity and jaundice, internal heat and quenching thirst.

Gorgon fruit, sweet, astringent, flat. Return spleen, kidney channel. Tonifying the kidney and strengthening essence, invigorating the spleen and arresting diarrhea, dispelling dampness and stopping leukorrhea. Used for nocturnal emission, enuresis, frequent urination, chronic diarrhea due to spleen deficiency, white turbidity, leukorrhea.

Semen Cuscuta, sweet, warm. Return liver, kidney, spleen channel. Nourishing liver and kidney, solidifying essence and reducing urination, preventing miscarriage, improving eyesight, and stopping diarrhea. For impotence and spermatorrhea, residual urination, enuresis, frequent urination, soreness of the waist and knees, dizziness and tinnitus, fetal leakage due to kidney deficiency, restless fetal movement, diarrhea due to deficiency of the spleen and kidney.

Flos Albiziae Julibrissin, sweet, flat. GUIXIN, Liver Channel. Relieve depression and soothe the nerves. For restlessness, depression and insomnia.

Bellflower, bitter, pungent, flat. Return lung meridian. Xuanfei, sore throat, expectorant, evacuation of pus. It is used for cough with excessive phlegm, uncomfortable chest, sore throat, hoarseness, pulmonary abscess with pus vomiting, sores and ulcers with pus that does not burst.

Anorexia is common disease, frequently-occurring disease. The basic pathogenesis is spleen dysfunction, stomach failure, and spleen-stomach disharmony. To invigorate the spleen and replenish qi, support the spleen and assist transportation, the present invention adjusts the gastrointestinal function, adjusts the mechanism of qi so that the spleen and stomach are transported and transformed vigorously, and the biochemistry of qi and blood is active. In the prescription, Atractylodes macrocephala and Chinese yam have the functions of invigorating the spleen and stomach, and they are the monarch drug; tangerine peel, regulating qi and invigorating the spleen, epimedium, regulating qi and relieving pain, tonifying the kidney and supporting yang, and warming the spleen and yang, both are ministerial drugs; hawthorn eliminates food accumulation , dissipate stagnation, astragalus nourishes qi and strengthens the surface, Gorgon fruit, dodder nourishes the spleen and relieves diarrhea as adjuvant drugs; Albizia julibrissin and Platycodon grandiflorum relieve stagnation and lungs are used as envoys. In a word, all kinds of medicines are combined to strengthen the spleen and help transportation, promote digestion and harmonize the middle. , can carry stagnant qi, and there is no worry about harming the body, the stomach can be tolerated, the spleen can be transported, and the spleen can be used to heal anorexia. Accompanying symptoms such as abnormal stool can fundamentally cure anorexia of spleen and stomach qi deficiency.

The technical solution adopted to solve the technical problem is the pharmaceutical composition for treating anorexia, which consists of the following pharmaceutical raw materials in proportions by weight: 16-22 parts of Atractylodes Rhizoma Rhizome, 13-21 parts of Chinese yam, 13-19 parts of tangerine peel, 11-15 parts of Epimedium, 8-16 parts of Hawthorn, 6-16 parts of Astragalus, 5-12 parts of Gorgon, 3-11 parts of Cuscuta, 3-6 parts of Albizia Julibrissin, 1-5 parts of Bellflower.

The preferred technical solution of the present invention is that the pharmaceutical composition of the present invention is prepared from the following raw materials in parts by weight: 19 parts of Atractylodes macrocephala, 17 parts of Chinese yam, 16 parts of tangerine peel, 13 parts of epimedium, 12 parts of hawthorn, and 11 parts of astragalus , 9 parts of Gorgon, 7 parts of Cuscuta, 5 parts of Albizia Julibrissin, and 3 parts of Campanulaceae.

The present invention also provides a preparation method of the pharmaceutical composition, specifically comprising the following steps:

The raw materials hawthorn, tangerine peel, epimedium, Chinese yam, astragalus, albizia juniper, gorgon, Atractylodes macrocephala, dodder, and platycodon grandiflora are respectively crushed into coarse powder, mixed evenly, and decocted twice in water with 3 times the total mass. Filtrate after 30 minutes each time, add 2 times the amount of ethanol with an alcohol concentration of 75% to the filtrate, reflux extraction twice, 60 minutes each time, filter, recover ethanol, concentrate the filtrate to a thick paste, and obtain.

Those skilled in the art can take the prepared pharmaceutical active ingredient of the present invention directly into medicine or add pharmaceutically acceptable adjuvants to prepare required preparations according to conventional techniques. For example, it can be made into commonly used tablets (dispersible tablets, effervescent tablets, orally disintegrating tablets, buccal tablets, chewable tablets, effervescent tablets), capsules (hard capsules, soft capsules), granules, pills (dropping pills) ), powders and other solid preparation forms can also be made into liquid preparation forms such as syrup, oral liquid, water, mixture and decoction. Therefore, besides the active ingredients, the pharmaceutical composition may also contain pharmaceutically acceptable auxiliary materials. Preferably, the pharmaceutical composition of the present invention is prepared into oral liquids, syrups, pills or powders, etc. according to conventional preparation techniques. When using the pharmaceutical composition of the present invention to treat anorexia, take the prepared syrup or oral liquid, each 10mL medicinal liquid, twice a day, every milliliter of syrup or oral liquid contains 0.3g of crude drug; or take the prepared powder, Each bag contains 6g of crude drug, half a bag each time, twice a day; or take the prepared pills, each pill contains 1g of crude drug, 3 capsules each time, twice a day.

The present invention also claims the application of the above-mentioned pharmaceutical composition in the preparation of a medicine for treating anorexia, especially in the preparation of a medicine for treating spleen-stomach qi deficiency type anorexia. After passing the safety evaluation of the pharmaceutical composition of the present invention, clinical case observations were selected to show that 94 cases of anorexia patients with spleen-stomach deficiency type were treated, and there were no dropout cases during the treatment process, and the clinical observations were all completed. After 2 courses of treatment, the total curative effect of the two groups of children was compared. The cure rate of the treatment group was 44.68%, and that of the control group was 8.51%. The control group was 74.47%. Compared with the total effective rate, the P values were all <0.05, and there was a significant difference. There were no abnormal changes in urine routine, stool routine, liver function, kidney function, and electrocardiogram before and after treatment in the two groups, and there were no adverse reactions or allergies to the drug. The results showed that the cure rate and effective rate of the treatment group were significantly better than those of the control group, and there were significant differences. Using the pharmaceutical composition of the present invention to treat anorexia, especially anorexia of spleen-stomach-qi deficiency type, has definite curative effect, is safe and reliable, can be used as an effective method for treating spleen-stomach-qi-deficiency type anorexia, and is worthy of popularization and use in clinic. At the same time, the treatment group was followed up for 1 year without any recurrence and no adverse reaction during treatment. This shows that the pharmaceutical composition of the present invention has reached the purpose of invigorating the spleen and harmonizing the stomach, eliminating food stagnation, regulating qi and removing dampness, and has played a significant effect of treating both symptoms and root causes.

The pharmaceutical composition of the present invention is a natural pure Chinese medicine preparation, the original medicine is easy to obtain, and the cost is low. It follows the prescription and medication principles of traditional Chinese medicine, significantly reduces adverse reactions and side effects, and has a high safety factor. It has been verified by clinical application. Toxic side effects and severe adverse reactions occur, and the total effective rate of clinical observation reaches 100%, which can better treat anorexia, especially anorexia of spleen-stomach deficiency type. Simultaneously, the medicine prepared by the invention is convenient for administration, improves the medication compliance of the anorexia patient, and improves the life quality of the patient.

detailed description

The present invention is further described below through specific examples, but the present invention is not limited to the following specific examples. Within the scope of the present invention or without departing from the content, spirit and scope of the present invention, changes, combinations or substitutions to the present invention are obvious to those skilled in the art and are included in the scope of the present invention Inside.

Example 1

Weigh each raw material of the present invention according to the following parts by weight: 19 parts of Atractylodes macrocephala, 17 parts of Chinese yam, 16 parts of tangerine peel, 13 parts of epimedium, 12 parts of hawthorn, 11 parts of astragalus, 9 parts of gorgon, 7 parts of dodder, 5 parts of Albizia juniper , 3 parts bellflower.

Preparation process: Grind the raw materials hawthorn, tangerine peel, epimedium, Chinese yam, astragalus, albizia juniper, gorgon, atractylodes macrocephala, dodder and platycodon root into coarse powder, mix evenly, and decoct in 3 times the total mass Twice, filter after 30 minutes each time, add 2 times the amount of ethanol with an alcohol concentration of 75% to the filtrate for reflux extraction twice, 60 minutes each time, filter, recover ethanol, and concentrate the filtrate to a thick paste. Those skilled in the art can make oral liquids, syrups, pills or powders and other commonly used oral preparations on the basis of the prepared pharmaceutical active ingredients of the present invention and take them directly or add pharmaceutically acceptable adjuvants according to conventional techniques.

When using the pharmaceutical composition of the present invention to treat anorexia, take the prepared syrup or oral liquid, each 10mL medicinal liquid, twice a day, every milliliter of syrup or oral liquid contains 0.3g of crude drug; or take the prepared powder, Each bag contains 6g of crude drug, 3g each time, twice a day; or take the prepared pills, each pill contains 1g of crude drug, 3 pills each time, twice a day.

Example 2

Weigh each raw material of the present invention according to the following parts by weight: 16 parts of Atractylodes macrocephala, 13 parts of Chinese yam, 13 parts of tangerine peel, 11 parts of epimedium, 8 parts of hawthorn, 6 parts of astragalus, 5 parts of gorgon, 3 parts of dodder, and 3 parts of albizia , 1 serving of bellflower.

Example 3

Weigh each raw material of the present invention according to the following parts by weight: 22 parts of Atractylodes macrocephala, 21 parts of Chinese yam, 19 parts of tangerine peel, 15 parts of epimedium, 16 parts of hawthorn, 16 parts of astragalus, 12 parts of Gorgon fruit, 11 parts of dodder seed, 6 parts of Albizia julibrissin , bellflower 5 parts.

Example 4

Weigh each raw material of the present invention according to the following parts by weight: 16 parts of Atractylodes macrocephala, 21 parts of Chinese yam, 13 parts of tangerine peel, 15 parts of epimedium, 8 parts of hawthorn, 16 parts of astragalus, 5 parts of gorgon, 11 parts of dodder, 3 parts of Albizia julibrissin , bellflower 5 parts.

Example 5

Weigh each raw material of the present invention according to the following parts by weight: 22 parts of Atractylodes macrocephala, 13 parts of Chinese yam, 19 parts of tangerine peel, 11 parts of epimedium, 16 parts of hawthorn, 6 parts of astragalus, 12 parts of gorgon, 3 parts of dodder, 6 parts of Albizia julibrissin , 1 serving of bellflower.

The preparation process of embodiment 2-5 is the same as embodiment 1.

The clinical observation of embodiment 6 pharmaceutical composition of the present invention treats anorexia

1. Case data: 94 children with anorexia (spleen-stomach qi deficiency) who met the inclusion criteria were selected from the pediatric ward and outpatient clinic of the hospital. The research was carried out by random grouping and parallel control method.

Among the observed objects, the treatment group: 47 cases, including 24 males and 23 females, aged 2-14 years, with a course of 2-12 months, 0 mild cases, 30 moderate cases, and 17 severe cases. Control group: 47 cases, including 22 males and 25 females, aged 2-14 years, with a course of 2-12 months, 0 mild cases, 29 moderate cases, and 18 severe cases. There was no significant difference between the two groups in terms of gender, age, course of disease, and illness after statistical processing (P>0.05), which was comparable.

2. Diagnosis basis:

1) Western medicine diagnostic criteria:

(1) Long-term loss of appetite, not greedy when seeing food, food intake reduced by more than 1/3-1/2 compared with before the disease, excluding other systemic diseases;

(2) Stagnated or slowed weight gain, poor eating habits or a history of improper feeding.

2) TCM diagnostic criteria:

(1) Long-term loss of appetite without other diseases.

(2) Shaohua complexion, thin body, but good spirit, no abdominal distension.

(3) There is a history of improper feeding, such as eating without a fixed amount, overeating raw or cold, sweet and savory, snacks or partial eclipse, etc.

3) TCM syndrome diagnostic criteria: spleen and stomach qi deficiency

Main symptoms: loss of appetite, decreased food intake.

Secondary symptoms: ① Pale complexion and emaciated body;

② Mental fatigue and lazy speech, body fatigue and weakness, muscle weakness;

③The stool is deformed or cannot digest food;

④ easy to sweat;

⑤ abdominal distension after eating;

⑥Pale tongue with thin white fur;

⑦ Weak pulse or purple stagnation of fingerprints, present in Fengguan.

4) Quantitative standard for the grading of symptoms and signs: the grading standard for anorexia symptoms in children: it was formulated with reference to the grading method for anorexia in children in the "Guiding Principles for Clinical Research of New Chinese Medicines" (Trial) promulgated by the State Drug Administration.

Grading scale for main symptoms of anorexia in children

Anorexia Secondary Symptom Grading and Quantification Scale

3. Inclusion criteria:

(1) Those who meet the diagnostic criteria of this disease;

(2) Those who meet the spleen-stomach qi deficiency syndrome in the TCM syndrome standard of this disease;

(3) Age 2-14 years old, gender is not limited;

(4) Did not use digestion-inducing drugs and digestive-aiding drugs within 1 week before the test;

(5) The subject's guardian signed the informed consent form.

4. Exclusion criteria:

(1) Combined with primary diseases such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system, mentally ill;

(2) Anorexia caused by other systemic diseases cannot be ruled out;

(3) Those who are known or may be allergic to the test drug and its components.

5. Rejection and shedding standards:

(1) After the case is selected, it is found that those who do not meet the inclusion criteria or meet the exclusion criteria;

(2) Serious adverse events occur, and the clinical trial of this case should be stopped according to the doctor's judgment;

(3) Cases with incomplete data or not prescribed medication after case selection, which will affect the judgment of curative effect or safety.

6. Usage and dosage:

Treatment group: take the oral liquid prepared in Example 5, take 10 mL of liquid medicine each time, twice a day, and every milliliter of syrup contains 0.3 g of crude drug.

Control group: Jianersu Granules (Z42020712, 10g*12 bags), boiled water, 10g each time for 2-5 years old, 3 times a day; 15g each time for 6-14 years old, 3 times a day.

14 days was a course of treatment, and both groups were given 2 courses of treatment.

7. Efficacy evaluation:

(1) Recovery: Symptoms are completely relieved, appetite and food intake return to normal levels, and the decline rate of symptom scores is greater than or equal to 95%;

(2) Significantly effective: the symptoms are basically relieved, the appetite is obviously improved, the food intake is restored to 3/4 of the original level, and the symptom score reduction rate is greater than or equal to 70%;

(3) Effective: the appetite has improved, the food intake has recovered, but it has not reached 3/4 of the original level, and the decline rate of symptom scores is greater than or equal to 30%;

(4) Ineffective: appetite and food intake were not significantly improved or aggravated, and the decrease rate of symptom scores was less than 30%.

8. Treatment effect:

During the course of treatment, there were no drop-out cases, and clinical observation was completed. After 2 courses of treatment, the total curative effect of the two groups of children was compared. The cure rate of the treatment group was 44.68%, and that of the control group was 8.51%. The control group was 74.47%. Compared with the total effective rate, the P values were all <0.05, and there was a significant difference. There were no abnormal changes in urine routine, stool routine, liver function, kidney function, and electrocardiogram before and after treatment in the two groups, and there were no adverse reactions or allergies to the drug. The results showed that the cure rate and effective rate of the treatment group were significantly better than those of the control group, and there were significant differences. Using the pharmaceutical composition of the present invention to treat anorexia, especially anorexia of spleen-stomach-qi deficiency type, has definite curative effect, is safe and reliable, can be used as an effective method for treating spleen-stomach-qi-deficiency type anorexia, and is worthy of popularization and use in clinic.

Comparison of curative effect between treatment group and control group

Claims (8)

1. A pharmaceutical composition for the treatment of anorexia, characterized in that it is made from the crude drug of the following parts by weight: 16-22 parts of Atractylodes macrocephala, 13-21 parts of Chinese yam, 13-19 parts of orange peel, 11-22 parts of epimedium 15 parts, 8-16 parts of Hawthorn, 6-16 parts of Astragalus, 5-12 parts of Gorgon, 3-11 parts of Cuscuta, 3-6 parts of Albizia Julibrissin, 1-5 parts of Campanulaceae. 2. The pharmaceutical composition as claimed in claim 1, characterized in that it is prepared from the following crude drugs in parts by weight: 19 parts of Atractylodes macrocephala, 17 parts of Chinese yam, 16 parts of tangerine peel, 13 parts of epimedium, and 12 parts of hawthorn , 11 parts of Astragalus, 9 parts of Gorgon, 7 parts of Cuscuta, 5 parts of Albizia Julibrissin, and 3 parts of Campanulaceae. 3. The pharmaceutical composition according to claim 1 or 2, wherein the pharmaceutical composition is an oral formulation. 4. The pharmaceutical composition according to claim 3, wherein the oral preparation is oral liquid, syrup, pill or powder. 5. The pharmaceutical composition according to claim 4, wherein the oral preparation is an oral liquid. 6. a method for preparing the pharmaceutical composition as claimed in claim 3, is characterized in that, comprises the steps: the raw material hawthorn of above-mentioned parts by weight, tangerine peel, epimedium, Chinese yam, astragalus, Albizia julibrissin, Gorgon fruit , Atractylodes Rhizoma Atractylodes Rhizome, Cuscuta Seed, Platycodon grandiflorum were crushed into coarse powder, mixed evenly, decocted twice in water with 3 times the total mass, filtered after 30 minutes each time, added 2 times the amount of filtrate with ethanol with an alcohol concentration of 75% and refluxed twice , 60min each time, filter, recover ethanol, and concentrate the filtrate to a thick paste. 7. the pharmaceutical composition as claimed in claim 1 or 2 is in the purposes in the preparation treatment anorexia medicine. 8. Use of the pharmaceutical composition as claimed in claim 1 or 2 in the preparation of an anorexia drug for the treatment of children with spleen-stomach deficiency.